3B BlackBio says EU legacy kit sales can continue through 2028

3B BlackBio Dx Limited says its TRUPCR® products can continue to be sold in the European Union as legacy devices until 31 December 2028, while BSI Group’s technical evaluation of product groups continues after the company passed IVDR-aligned quality management system audits in November 2025.

How long can 3B BlackBio sell legacy kits in the EU?

3B BlackBio says it can sell its products as legacy devices until 31 December 2028 under the stated transition period. The company is progressing an In Vitro Diagnostic Regulation, or IVDR, transition plan for key TRUPCR® kits to comply with Regulation (EU) 2017/746, rather than treating the legacy-device route as a permanent arrangement.

Regulation (EU) 2017/746 was published on 5 April 2017, repealing Directive 98/79/EC, according to the presentation. 3B BlackBio says the strengthened regulatory framework is applicable from 26 May 2026 and that IVDR certifications would be received before the 31 December 2028 transition period ends.

What has BSI Group completed for 3B BlackBio?

BSI Group has completed IVDR-aligned quality management system, or QMS, audits for 3B BlackBio and has been appointed as its notified body for IVDR conformity assessment. The company says it signed an agreement with BSI Group, while its regulatory team and multiple departments work on implementing the IVDR requirements.

The BSI certificate shown in the presentation is for 3B BlackBio Biotech Limited and records certificate number MD 813787 under ISO 13485:2016. Its scope covers the design, development, manufacturing, sales and distribution of polymerase chain reaction, rapid and enzyme-linked immunosorbent assay, or ELISA, in-vitro diagnostic kits for oncology, genetics, infectious, blood-borne and vector-borne diseases.

The certificate lists an original registration date of 23 October 2024, a latest revision date of 23 January 2025, an effective date of 1 February 2025 and an expiry date of 1 February 2028. The completed November 2025 QMS audit and the technical evaluation of product groups are separate steps in the IVDR work described by 3B BlackBio.

Which 3B BlackBio products have IVDR status?

3B BlackBio says further technical evaluation of product groups is under way, but does not name the individual TRUPCR® kits in those groups. The presentation therefore does not provide a kit-by-kit assessment timetable, product classification or certification decision for the portfolio still undergoing evaluation.

The company separately states that more than 40 key assays are CE-IVD marked following the new IVDR regulations. It also says on its future-outlook page that Coris has been granted IVDR certification for two main antimicrobial resistance, or AMR, products, distinguishing those two products from the continuing technical evaluation of other product groups.

The BSI ISO 13485:2016 certificate covers PCR, rapid and ELISA diagnostic kits across five stated application areas, including oncology and infectious diseases. That QMS scope does not assign IVDR status to each assay, while 3B BlackBio’s page 31 disclosure says technical evaluation of product groups remains in progress.

What does the IVDR transition mean for 3B BlackBio?

The IVDR transition gives 3B BlackBio a stated route to continue EU sales of its products as legacy devices through 31 December 2028 while it seeks certification for key TRUPCR® kits. Management’s disclosed objective is to receive IVDR certifications before that transition period ends.

The work extends beyond the November 2025 audit because the company says its regulatory team and multiple departments are implementing IVDR requirements. The ISO 13485:2016 certificate covers activities from design and development through manufacturing, sales and distribution, but the presentation does not quantify EU revenue or identify the share of sales represented by product groups under technical evaluation.

The presentation places the operational deadline alongside a fixed regulatory date: legacy-device sales can continue to 31 December 2028, whereas BSI’s technical evaluation remains under way. It does not disclose an expected completion date for BSI’s assessment of any named TRUPCR® product group.

What should investors monitor before December 2028?

Investors should monitor whether 3B BlackBio reports completed IVDR certifications for the key TRUPCR® kits undergoing technical evaluation. The company has identified November 2025 as the point at which it passed IVDR-aligned QMS audits and 31 December 2028 as the end of the legacy-device transition period.

A second disclosed date is 1 February 2028, when certificate MD 813787 is shown as expiring, about 11 months before the 31 December 2028 transition deadline. The presentation names BSI Group as the notified body but gives no renewal schedule or product-group certification calendar, making future updates on these two matters relevant to the stated plan.

Conclusion

3B BlackBio has disclosed a transition path under which its products can remain on the EU market as legacy devices until 31 December 2028. The company has appointed BSI Group as its notified body, passed IVDR-aligned QMS audits in November 2025, and shown an ISO 13485:2016 certificate covering diagnostic-kit activities, while technical evaluation of product groups continues.

What to watch next is management’s stated plan to obtain IVDR certifications before the December 2028 deadline, together with the status of ISO 13485:2016 certificate MD 813787 before its 1 February 2028 expiry. The presentation does not set out a product-by-product evaluation schedule, so certification updates for key TRUPCR® kits will indicate progress against that plan.